US-based ReCor Medical has begun enrolment for its RADIANCE-HTN clinical trial of Paradise Renal Denervation System on blood pressure to treat hypertension.
The blinded, randomised and sham-controlled RADIANCE-HTN trial is being conducted to assess the efficacy of the Paradise system in reducing the blood pressure level in two patient populations.
The two patient populations are those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of three antihypertensive medications.
Investigational device exemption (IDE) approved study plans to involve 292 patients and will be conducted in the US, the UK, France, Germany, and The Netherlands.
The study co-primary investigator Dr Laura Mauri said: "We are pleased with the progress of RADIANCE-HTN, and understand that we are involved in an important effort to evaluate the efficacy of renal denervation with the Paradise System in patients with hypertension.
"We have seen that both physicians and patients are keenly interested in the potential of the Paradise treatment.
“Our focus for the coming year will be to consent and randomise eligible study subjects and ensure that the RADIANCE-HTN results reflect the true performance of Paradise in the study."
Recor Medical’s Paradise Renal Denervation System has been developed as a minimally invasive procedure to treat overactive nerves leading to kidney.
Its procedure involves insertion of a small flexible catheter through a small incision made in the groin and placing the catheter in the artery supplying the kidney.
After being placed, ultrasound energy (sound waves) is released to the tissue surrounding the artery for several seconds.
The ultrasound energy produces heat to reduce the over-activity of the nerves leading to the kidney.
The device is removed after the treatment.